Table 1. Characteristics and major... | American Society of Hematology

Table 1.

Characteristics and major outcomes of randomized controlled trials on use of 4-factor PCC vs FFP

	Demeyere et al²⁵	Sarode et al²³	Goldstein et al²⁴
Patients, n	40	216	181
Clinical setting	Cardiopulmonary bypass	Major bleeding	Urgent surgical/invasive procedure
Intervention	Cofact vs FFP	Kcentra vs FFP	Kcentra vs FFP
Primary end point, n (%)	Patients reaching INR ≤1.5	24-h hemostatic efficacy	Effective hemostasis
Primary end point, n (%)	7 (44) vs 0; P = .007	71 (72) vs 68 (65)*	78 (90) vs 61 (75)†
Mortality (d 45)	Data not provided	10 (9.7) vs 5 (4.6)	3 (3) vs 8 (9)
Thrombotic events, n (%)	Data not provided	8 (7.8) vs 7 (6.4)	6 (7) vs 7 (8)
Fluid overload, n (%)	Data not provided	0 vs 7 (6.4)	3 (3) vs 11 (13)

	Demeyere et al²⁵	Sarode et al²³	Goldstein et al²⁴
Patients, n	40	216	181
Clinical setting	Cardiopulmonary bypass	Major bleeding	Urgent surgical/invasive procedure
Intervention	Cofact vs FFP	Kcentra vs FFP	Kcentra vs FFP
Primary end point, n (%)	Patients reaching INR ≤1.5	24-h hemostatic efficacy	Effective hemostasis
Primary end point, n (%)	7 (44) vs 0; P = .007	71 (72) vs 68 (65)*	78 (90) vs 61 (75)†
Mortality (d 45)	Data not provided	10 (9.7) vs 5 (4.6)	3 (3) vs 8 (9)
Thrombotic events, n (%)	Data not provided	8 (7.8) vs 7 (6.4)	6 (7) vs 7 (8)
Fluid overload, n (%)	Data not provided	0 vs 7 (6.4)	3 (3) vs 11 (13)

Primary end point was 4-factor PCC non-inferior to plasma: P value for non-inferiority = .0045.

P = .0142 for superiority of 4-factor PCC to plasma.